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Clinical Trials in the USA / NCT05046613
Recruiting Observational

Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant

NCT05046613 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Observational
Started
2021-09-23
Last updated
2026-10-29

Condition(s) studied

Migraine

Investigational drug(s) / intervention(s)

RimegepantNot taking Rimegepant

Rimegepant: 75mg

Not taking Rimegepant: No rimegepant

Study summary

The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.

Eligibility

Sex
FEMALE
Min age
0 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception) * Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy Exclusion Criteria: • Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy

Primary outcome measure(s)

  • Major congenital malformation (birth defect) — Annually beginning April 2022
    Healthcare provider report through the registry

Trial sites (1)

FacilityCityRegionStatus
Evidera, a PPD business unit Wilmington North Carolina Recruiting

On this site

📄 Nurtec ODT (rimegepant) drug profile →

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Other trials for the same condition

Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy Active, not recruiting
External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy Recruiting
Observational Study of Oral Atogepant to Evaluate Real-World Effectiveness in Adult Participants With Migraine Active, not recruiting
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine Active, not recruiting
Nerivio Efficacy Under High-Frequency Use Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05046613 on ClinicalTrials.gov ↗ ← All trials in the USA